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Paul Kiesel
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FDA Holds Hearing on Safety of Drug Coated Heart Stents

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FDA reviews dangers of heart stents. Drug coated heart stents under review by governmental agency.

Last week the FDA brought together a distinguished group of scientific experts for two days of hearings on the safety of drug coated heart stents. These small mesh tubes are designed to prop open diseased arteries which have been clogged by deadly plaque build up.

Since the introduction of drug coated stents in 2003, they have become a first choice in medical devices intended to fight the artery clogging effects of heart disease. However, recent studies have indicated that the drug coated devices can cause fatal blood clots long after the stents have been implanted.

The FDA has come under strong criticism for not properly monitoring the safety of new drugs and medical devices it has licensed for use. It has been castigated for the proliferation of defective drugs and medical devices that have been proven to cause injury and death. In the case of heart stents, the FDA approved their use based upon studies of patients with relatively simple heart problems, involving a single arterial blockage, without serious complications such as a heart attack.

The primary issue is that doctors have been using the drug coated mesh stents for patients with more complicated arterial disease, such as multiple blocked arteries. In addition, patients using the newer stents are usually prescribed drugs to thin the blood in order to prevent clotting. There are a number of circumstances where patients, for other medical reasons, can’t use blood thinning drugs. It is now thought that these patients are not candidates for the newer stents because of increased risk of serious heart attacks.

The recent FDA hearings have made clear that drug coated heart stents require further research into their potential risks. At a minimum the FDA should reformulate warning labels so that doctors and patients can make more informed decisions as to whether the benefits of drug coated heart stents outweigh their risks.

Kiesel Boucher Larson specializes in defective medical devise and drug litigation and has a team of experienced lawyers and scientific experts, all of whom successfully prosecute these highly complex cases.